[IWB982] | Subject Matter Expert (Fill and Finish process)

[IWB982] | Subject Matter Expert (Fill and Finish process)

13 feb
|
Oxford Global Resources
|
Roma Provincia

13 feb

Oxford Global Resources

Roma Provincia

Oxford Global Resources is looking for a SME Lead, specialized in aseptic fill-finish for a very important project based in Italy for a multinational pharmaceutical company.



The description of the main responsibilitiesand requirements for this role are:



Hands on experience with aseptic fill-finish, using isolator technology and RABS technology.



- Hands on experience with filling line qualification and start up - smoke studies, media fills (interventions), filling accuracy, etc...

- Experience with disposable systems both for filling line (peristaltic pump) as well as for buffer prep and compounding.

- Experience with operation and qualification of cleaning and sanitizing - fumigation/VHP - systems.



- Experience with EMA and FDA guidelines specifically for compounding / fill finish.

- Can lead improvement programs and train on-site operational teams to meet EMA / FDA requirements.

- Experience with leading (first line) investigations, excellent documentation and reporting skills.

- Able to support, write/review regulatory filing.

- Coordinate with TLI / Technical Operations platform and planning team to ensure project alignment.



If you are interesting in this project, don't hesitate and apply attaching your CV.

Puoi trovare l'offerta di lavoro originale su Kit Lavoro:
https://www.kitlavoro.it/lavoro/21356799/iwb982-subject-matter-expert-fill-and-finish-process-roma-provincia/?utm_source=html

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